Cleared Traditional

K242406 - SiOxC Cream (FDA 510(k) Clearance)

Mar 2025
Decision
211d
Days
-
Risk

K242406 is an FDA 510(k) clearance for the SiOxC Cream. This device is classified as a Dressing, Wound, Drug.

Submitted by Sioxmed, LLC (Clemmons, US). The FDA issued a Cleared decision on March 13, 2025, 211 days after receiving the submission on August 14, 2024.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K242406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2024
Decision Date March 13, 2025
Days to Decision 211 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO - Dressing, Wound, Drug
Device Class -

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